International safety notice
As a result of an investigation at an overseas manufacturer, temperature calibration equipment for target products manufactured or repaired between May 2022 and May 2024. A problem was found in some parts of the installation. In rare cases, incorrect results may be obtained for some measurement items. Therefore, we will carry out a voluntary recall to repair the affected equipment by removing it and recalibrating the temperature.
Japan / PMDA Recalls · JPN · Aug 14, 2024
Key facts
| Title | As a result of an investigation at an overseas manufacturer, temperature calibration equipment for target products manufactured or repaired between May 2022 and May 2024. A problem was found in some parts of the installation. In rare cases, incorrect results may be obtained for some measurement items. Therefore, we will carry out a voluntary recall to repair the affected equipment by removing it and recalibrating the temperature. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Genetic analysis device Sales name: (1)FilmArray Torch system (2) FilmArray system |
| Manufacturer | bioMérieux Japan Co., Ltd. |
| Models | TM09504, TM20413, TM08617, TM17112, TM13661, TM16188, TM16407, TM08931, TM02105, TM07294, 2FA05349, TM11137 and 69 more |
| Date | Aug 14, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1